PHRM06010 2019 Introduction to Drug Discovery and Development
Full Title
Introduction to Drug Discovery and Development
Transcript Title
Introduction to Drug Discovery
Code
PHRM06010
Attendance
75 %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
06 - Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Declan Shelly
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science with Drug Development
SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science with Drug Development
SG_SSCIE_B07 201900 Bachelor of Science in Science
SG_SSCIE_H08 201900 Bachelor of Science (Honours) in Science
SG_SSCIE_C06 201900 Higher Certificate in Science
SG_SPHAR_C06 202100 Higher Certificate in Science in Pharmaceutical Science
Description
This module introduces students to historical and contemporary aspects of drug discovery and development and examines the importance of regulation within the pharmaceutical sector.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Discuss the drug discovery process, from both historical and comtemperory perspective.
2.
Compare drug discovery from natural products and synthetic processes.
3.
Distinguish between medicines and non medicinal products.
4.
Describe the medicinal product development process and state the significant features attendant with each phase of this process.
5.
State the historical reasons for the introduction of regulations governing the manufacture and distribution of medicines.
6.
Explain how regulatory authorities use regulations to control and protect the industry.
Teaching and Learning Strategies
This module will be delivered full-time. It will include lectures and videos.This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources.
Module Assessment Strategies
Students will be assessed using a range of assessment methods including essays, oral presentations, posters and short answer questions.
The student must achieve 40% overall in order to pass the module.
Repeat Assessments
Students may repeat Continuous Assessment as required
Indicative Syllabus
Historical perspective on medicinal product development.
Development of pharmacoepias - BP, EU, US.
Development of pharmaceutical product from natural sources and via synthetic routes.
Pharmaceutical Regulations in the U.S. and the E.U.
International and national regulatory agencies - IMB, MHRA, EMEA, FDA..
Drug development process - pre-clinical , clinical trials, product approval.
Content of the marketing authorisiation application (CTD - Europe, US, and Japan).
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Class Discussion | Formative | Performance Evaluation | 0 % | OnGoing | 1,2,3,4,5,6 |
| 2 | Continuous Assessment | Coursework Assessment | Assessment | 100 % | OnGoing | 1,2,3,4,5,6 |
Module Resources
Non ISBN Literary Resources
None
Journal Resources
None
Other Resources
Module Lecture Notes
Additional Information
None